Результаты обработки

Accuracy (сравнение с Ground Truth)

70.3%
71 из 101 совпадений с экспертной оценкой
101
Всего пациентов
71
Included (Подходят)
30
Excluded (Не подходят)
0
Not Enough Info
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Детальные результаты по пациентам

Included (Подходят) 71

+
sigir-20141 GT: not enough information
Included

Обоснование:

  • + Patients of chronic stable angina with abnormal Ex... (score: 0.51)
  • + Patient must understand and be willing, able and l... (score: 0.77)
  • No exclusion criteria met
Inclusion met: 3 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the diary cards.
🏥 Из анамнеза пациента
"The patient will provide informed consent, and will comply with the trial protocol without any practical issues."
Similarity: 77% Confidence: high
inclusion MET
📋 Критерий
Patient must be able to give voluntary written informed consent.
🏥 Из анамнеза пациента
"The patient will provide informed consent, and will comply with the trial protocol without any practical issues."
Similarity: 68% Confidence: high
inclusion MET
📋 Критерий
Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.
🏥 Из анамнеза пациента
"Physical examination is normal."
Similarity: 51% Confidence: medium
exclusion NOT MET
📋 Критерий
Cardiac arrhythmias or II or III degree AV block
🏥 Из анамнеза пациента
"Physical examination is normal."
Similarity: 65% Confidence: low
exclusion NOT MET
📋 Критерий
Myocardial infarction in < 6 months
🏥 Из анамнеза пациента
"Physical examination is normal."
Similarity: 61% Confidence: low
exclusion NOT MET
📋 Критерий
Patients not eligible for Tc 99m SPECT
🏥 Из анамнеза пациента
"The patient will provide informed consent, and will comply with the trial protocol without any practical issues."
Similarity: 51% Confidence: low
exclusion NOT MET
📋 Критерий
Severe anemia (Hb 7G/dl)
🏥 Из анамнеза пациента
"The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration."
Similarity: 50% Confidence: low
exclusion NOT MET
📋 Критерий
Unstable angina
🏥 Из анамнеза пациента
"Physical examination is normal."
Similarity: 50% Confidence: low
exclusion NOT MET
📋 Критерий
Hypertension of > 170/100 mm of Hg
🏥 Из анамнеза пациента
"She is known to have hypertension and obesity."
Similarity: 48% Confidence: low
exclusion NOT MET
📋 Критерий
Geographical inaccessibility for treatment or follow-up evaluations
🏥 Из анамнеза пациента
"The patient will provide informed consent, and will comply with the trial protocol without any practical issues."
Similarity: 45% Confidence: low
exclusion NOT MET
📋 Критерий
Pregnant and nursing women
🏥 Из анамнеза пациента
"She currently takes no medications."
Similarity: 44% Confidence: low
exclusion NOT MET
📋 Критерий
Congestive cardiac failure
🏥 Из анамнеза пациента
"She is known to have hypertension and obesity."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
Patients in whom beta blockers are contraindicated
🏥 Из анамнеза пациента
"The patient will provide informed consent, and will comply with the trial protocol without any practical issues."
Similarity: 41% Confidence: low
exclusion NOT MET
📋 Критерий
Known hypersensitivity to nicorandil
🏥 Из анамнеза пациента
"She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Valvular heart disease and cardiomyopathy
🏥 Из анамнеза пациента
"She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease."
Similarity: 37% Confidence: low
exclusion NOT MET
📋 Критерий
IDDM (Type-1 diabetes mellitus)
🏥 Из анамнеза пациента
"She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease."
Similarity: 35% Confidence: low
exclusion NOT MET
📋 Критерий
Significant liver or renal dysfunction
🏥 Из анамнеза пациента
"She is known to have hypertension and obesity."
Similarity: 35% Confidence: low
exclusion NOT MET
📋 Критерий
On calcium channel blockers
🏥 Из анамнеза пациента
"She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease."
Similarity: 34% Confidence: low
exclusion NOT MET
📋 Критерий
Systolic blood pressure < 100 mm Hg
🏥 Из анамнеза пациента
"She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease."
Similarity: 29% Confidence: low
inclusion UNKNOWN
📋 Критерий
Age 25 to 65 years
🏥 Из анамнеза пациента
"The latest episode of pain ended half an hour prior to her arrival."
Similarity: 38% Confidence: low
inclusion UNKNOWN
📋 Критерий
Male and female
🏥 Из анамнеза пациента
"The patient will provide informed consent, and will comply with the trial protocol without any practical issues."
Similarity: 34% Confidence: low
dapa-001 GT: included
Included

Обоснование:

  • + Provision of signed informed consent prior to any ... (score: 0.76)
  • + Male or female, aged ≥18 years (score: 1.00)
  • No exclusion criteria met
Inclusion met: 7 Inclusion not met: 0 Unknown: 0 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 66-year-old man with chronic symptomatic HFrEF for 3 years."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38% on echo 6 weeks ago."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 36 mL/min/1.73 m²."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Will provide informed consent."
Similarity: 76% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 640 pg/mL (sinus rhythm)."
Similarity: 61% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 66-year-old man with chronic symptomatic HFrEF for 3 years."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II, stable for 4 months."
Similarity: 58% Confidence: medium
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No MI/stroke/revascularization in last 3 months."
Similarity: 73% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No MI/stroke/revascularization in last 3 months."
Similarity: 71% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No MI/stroke/revascularization in last 3 months."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II, stable for 4 months."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 108 mmHg without dizziness."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II, stable for 4 months."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II, stable for 4 months."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No MI/stroke/revascularization in last 3 months."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 36 mL/min/1.73 m²."
Similarity: 0% Confidence: high
dapa-002 GT: included
Included

Обоснование:

  • + Provision of signed informed consent prior to any ... (score: 0.72)
  • + Male or female, aged ≥18 years (score: 1.00)
  • No exclusion criteria met
Inclusion met: 7 Inclusion not met: 0 Unknown: 0 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 69-year-old woman with chronic HFrEF due to ischemic cardiomyopathy."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 40% documented 1 month ago."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 31."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Consents to trial."
Similarity: 72% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 610 pg/mL (no AF)."
Similarity: 61% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"On guideline-directed HF therapy."
Similarity: 51% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 71% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent acute coronary syndrome."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 100 without symptoms of hypotension."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent acute coronary syndrome."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent acute coronary syndrome."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"Consents to trial."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 31."
Similarity: 0% Confidence: high
dapa-003 GT: excluded
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 63-year-old man with nonischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 44."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 590 pg/mL (sinus rhythm)."
Similarity: 65% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 49% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No prior SGLT2 inhibitor."
Similarity: 74% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"On ACEi + beta-blocker; MRA planned."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"A 63-year-old man with nonischemic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"Stable symptoms."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 44."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Stable symptoms."
Similarity: 36% Confidence: low
dapa-004 GT: not enough information
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + LVEF≤40% (score: 1.00)
  • No exclusion criteria met
Inclusion met: 5 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 71-year-old man with chronic HFrEF and intermittent AF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 40."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 880 pg/mL with documented AF at screening."
Similarity: 61% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent MI/stroke."
Similarity: 73% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent MI/stroke."
Similarity: 64% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent MI/stroke."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 106."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 40."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 43% Confidence: low
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 32% Confidence: low
dapa-007 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.51)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 74-year-old man with ischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 32."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 1,200 pg/mL."
Similarity: 71% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA III, stable."
Similarity: 51% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No prior SGLT2 inhibitor."
Similarity: 74% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 98 without hypotensive symptoms."
Similarity: 60% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA III, stable."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"A 74-year-old man with ischemic HFrEF."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III, stable."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III, stable."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"A 74-year-old man with ischemic HFrEF."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"A 74-year-old man with ischemic HFrEF."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 32."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"On full GDMT."
Similarity: 34% Confidence: low
dapa-009 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 47."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 610 pg/mL."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 55% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 71% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 102."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 47."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 35% Confidence: low
dapa-011 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.48)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 30%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 34."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 1,800 pg/mL."
Similarity: 70% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
Similarity: 48% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 116."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 34."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 31% Confidence: low NEGATION DETECTED
dapa-012 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 64-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 30 exactly on repeat labs."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 620 pg/mL."
Similarity: 60% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 64-year-old man with chronic HFrEF."
Similarity: 53% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 30 exactly on repeat labs."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 34% Confidence: low
dapa-014 GT: not enough information
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.55)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 61-year-old man with HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 42."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 900 pg/mL with AF documented on ECG."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 61-year-old man with HFrEF."
Similarity: 52% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 105."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 42."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 33% Confidence: low
dapa-016 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 58-year-old woman with nonischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 70."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
Similarity: 64% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 49% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No diabetes."
Similarity: 75% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"A 58-year-old woman with nonischemic HFrEF."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"A 58-year-old woman with nonischemic HFrEF."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 70."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 31% Confidence: low
dapa-017 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 35."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 605 pg/mL."
Similarity: 64% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
Similarity: 53% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 96."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 35."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 33% Confidence: low
dapa-018 GT: excluded
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 65-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 37."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 575 pg/mL."
Similarity: 66% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 65-year-old man with chronic HFrEF."
Similarity: 55% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 109."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 33% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 37."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 109."
Similarity: 36% Confidence: low
dapa-019 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.54)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 31%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 33."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 1,500 pg/mL."
Similarity: 70% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 95 without symptoms."
Similarity: 71% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"SBP 95 without symptoms."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 33."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 95 without symptoms."
Similarity: 35% Confidence: low
dapa-021 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.55)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 41."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 700 pg/mL."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
Similarity: 52% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"T2DM controlled, no SGLT2 use."
Similarity: 66% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 56% Confidence: low
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 54% Confidence: low
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: low
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 46% Confidence: low
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"T2DM controlled, no SGLT2 use."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 104."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 41."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 31% Confidence: low
dapa-022 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 71-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 31."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
Similarity: 64% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 71-year-old woman with chronic HFrEF."
Similarity: 54% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 use."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"Recent hospitalization for HF 10 months ago."
Similarity: 60% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: low
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: low
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"Recent hospitalization for HF 10 months ago."
Similarity: 50% Confidence: low
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No SGLT2 use."
Similarity: 46% Confidence: low
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"Recent hospitalization for HF 10 months ago."
Similarity: 45% Confidence: low
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"Recent hospitalization for HF 10 months ago."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 31."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 33% Confidence: low
dapa-024 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 62-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 59."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 660 pg/mL."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 62-year-old woman with chronic HFrEF."
Similarity: 52% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 36% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 59."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 37% Confidence: low
dapa-026 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 63-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 48."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 690 pg/mL."
Similarity: 66% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 63-year-old man with chronic HFrEF."
Similarity: 49% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 use."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 99."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 48."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 33% Confidence: low
dapa-027 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.51)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 75-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 30."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
Similarity: 67% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 75-year-old woman with chronic HFrEF."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 51% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 96 without symptoms."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"SBP 96 without symptoms."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 30."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 96 without symptoms."
Similarity: 34% Confidence: low
dapa-028 GT: not enough information
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 64-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 46."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP not available in records."
Similarity: 70% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 64-year-old man with chronic HFrEF."
Similarity: 53% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 114."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 33% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 46."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"NT-proBNP not available in records."
Similarity: 36% Confidence: low
dapa-029 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 61-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 51."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 620 pg/mL."
Similarity: 60% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 61-year-old woman with chronic HFrEF."
Similarity: 53% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No diabetes."
Similarity: 75% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 use."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: low
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: low
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: low
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 107."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 51."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"No SGLT2 use."
Similarity: 32% Confidence: low
dapa-030 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.55)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 34."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 605 pg/mL."
Similarity: 64% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
Similarity: 52% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 95 with no orthostatic symptoms."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 exposure."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 exposure."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 34."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 33% Confidence: low
dapa-031 GT: included
Included

Обоснование:

  • + Provision of signed informed consent prior to any ... (score: 0.76)
  • + Male or female, aged ≥18 years (score: 1.00)
  • No exclusion criteria met
Inclusion met: 7 Inclusion not met: 0 Unknown: 0 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF for 3 years."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 40% on echocardiography 4 weeks ago."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 33 mL/min/1.73 m²."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Will provide informed consent."
Similarity: 76% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 610 pg/mL."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II, clinically stable for 5 months."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF for 3 years."
Similarity: 54% Confidence: medium
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No MI/unstable angina/stroke/TIA or revascularization within 3 months."
Similarity: 78% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No MI/unstable angina/stroke/TIA or revascularization within 3 months."
Similarity: 64% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No MI/unstable angina/stroke/TIA or revascularization within 3 months."
Similarity: 64% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 97 mmHg without dizziness."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"LVEF 40% on echocardiography 4 weeks ago."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II, clinically stable for 5 months."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II, clinically stable for 5 months."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No MI/unstable angina/stroke/TIA or revascularization within 3 months."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 33 mL/min/1.73 m²."
Similarity: 0% Confidence: high
dapa-032 GT: excluded
Included

Обоснование:

  • + Provision of signed informed consent prior to any ... (score: 0.72)
  • + Male or female, aged ≥18 years (score: 1.00)
  • No exclusion criteria met
Inclusion met: 7 Inclusion not met: 0 Unknown: 0 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF for 3 years."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 40% on recent echo."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 34."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Consents to participation."
Similarity: 72% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 590 pg/mL."
Similarity: 68% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II, stable."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF for 3 years."
Similarity: 54% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 99 without hypotensive symptoms."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II, stable."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"LVEF 40% on recent echo."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II, stable."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 34."
Similarity: 0% Confidence: high
dapa-033 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.51)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 41."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 880 pg/mL."
Similarity: 67% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA III, stable."
Similarity: 51% Confidence: medium
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No MI/stroke/revascularization within 3 months."
Similarity: 73% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No MI/stroke/revascularization within 3 months."
Similarity: 71% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No MI/stroke/revascularization within 3 months."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"She was hospitalized for worsening HF 6 months ago."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA III, stable."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No MI/stroke/revascularization within 3 months."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III, stable."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"No MI/stroke/revascularization within 3 months."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 41."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 110."
Similarity: 34% Confidence: low
dapa-039 GT: not enough information
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + LVEF≤40% (score: 1.00)
  • No exclusion criteria met
Inclusion met: 5 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 71-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 39."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP is not available in current records."
Similarity: 69% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 52% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 106."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 39."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 43% Confidence: low
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"NT-proBNP is not available in current records."
Similarity: 38% Confidence: low
dapa-040 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 55."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 620 pg/mL."
Similarity: 60% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 47% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 95 mmHg without hypotensive symptoms."
Similarity: 74% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 55."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 34% Confidence: low
dapa-041 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.47)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 44."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 910 pg/mL."
Similarity: 66% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 47% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III, stable for 6 months."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA III, stable for 6 months."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III, stable for 6 months."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 108."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA III, stable for 6 months."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III, stable for 6 months."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA III, stable for 6 months."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 44."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 35% Confidence: low
dapa-042 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 67-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 50."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 420 pg/mL."
Similarity: 65% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 67-year-old woman with chronic HFrEF."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"Hospitalized for worsening HF 9 months ago."
Similarity: 60% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 50."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 34% Confidence: low
dapa-043 GT: excluded
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 67-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 51."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 390 pg/mL."
Similarity: 69% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 67-year-old woman with chronic HFrEF."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"Hospitalized for worsening HF 9 months ago."
Similarity: 60% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 119."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 51."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 119."
Similarity: 35% Confidence: low
dapa-044 GT: excluded
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.55)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 60-year-old man with ischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 58."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 800 pg/mL."
Similarity: 65% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"He had an acute myocardial infarction treated with PCI 2 months ago."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"He had an acute myocardial infarction treated with PCI 2 months ago."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"He had an acute myocardial infarction treated with PCI 2 months ago."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"He had an acute myocardial infarction treated with PCI 2 months ago."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"He had an acute myocardial infarction treated with PCI 2 months ago."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 58."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 34% Confidence: low
dapa-045 GT: included
Included

Обоснование:

  • + Male or female, aged ≥18 years (score: 1.00)
  • + Established documented diagnosis of symptomatic HF... (score: 0.57)
  • No exclusion criteria met
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 69-year-old man with chronic nonischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 37."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 660 pg/mL."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"SBP 102 without symptoms."
Similarity: 49% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 102 without symptoms."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 37."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 37% Confidence: low
emp-001 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 67-year-old man with chronic HFrEF for 4 years."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 65% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 900 pg/mL (sinus rhythm)."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 67-year-old man with chronic HFrEF for 4 years."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"No recent MI or stroke."
Similarity: 72% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 108 without hypotensive symptoms."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 108 without hypotensive symptoms."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 67-year-old man with chronic HFrEF for 4 years."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 28."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 900 pg/mL (sinus rhythm)."
Similarity: 34% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 28."
Similarity: 42% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 38% Confidence: low
emp-002 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 60% Confidence: high
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,400 pg/mL."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,400 pg/mL."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
Similarity: 51% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 66% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 64% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 104."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 104."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,400 pg/mL."
Similarity: 35% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 35% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 22."
Similarity: 40% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 36% Confidence: low
emp-004 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 750 pg/mL."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 750 pg/mL."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 49% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
Similarity: 48% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100 without dizziness."
Similarity: 71% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100 without dizziness."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 750 pg/mL."
Similarity: 33% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 60."
Similarity: 38% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 36% Confidence: low
emp-005 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.46)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 30%."
Similarity: 64% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 30%."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 30%."
Similarity: 49% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 30%."
Similarity: 46% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 118."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 118."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 19."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 35% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
Similarity: 35% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 31% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 30%."
Similarity: 40% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 19."
Similarity: 40% Confidence: low
emp-006 GT: not enough information
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.59)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF and AF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,100 pg/mL with AF on ECG."
Similarity: 71% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,100 pg/mL with AF on ECG."
Similarity: 70% Confidence: high
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,100 pg/mL with AF on ECG."
Similarity: 69% Confidence: high
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,100 pg/mL with AF on ECG."
Similarity: 66% Confidence: high
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP 1,100 pg/mL with AF on ECG."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 112."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 112."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF and AF."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,100 pg/mL with AF on ECG."
Similarity: 36% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 36% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 43% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 39% Confidence: low
emp-007 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 58-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 63% Confidence: high
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 61% Confidence: high
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 66% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 64% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 101."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"Type 2 diabetes on metformin."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"Type 2 diabetes on metformin."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 101."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 34% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 33."
Similarity: 41% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 36% Confidence: low
emp-008 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 920 pg/mL."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 920 pg/mL."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 920 pg/mL."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 920 pg/mL."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 41%."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 124."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 124."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 920 pg/mL."
Similarity: 36% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 32% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 54."
Similarity: 39% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 41%."
Similarity: 33% Confidence: low
emp-009 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.48)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 71-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 28%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
Similarity: 48% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 28%."
Similarity: 47% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 107."
Similarity: 58% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 107."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 71-year-old man with chronic HFrEF."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 21."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
Similarity: 36% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 28%."
Similarity: 40% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 28%."
Similarity: 39% Confidence: low
emp-011 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 60% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 900 pg/mL."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 900 pg/mL."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
Similarity: 53% Confidence: medium
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 103."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 103."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 24."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 36% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 900 pg/mL."
Similarity: 35% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 24."
Similarity: 41% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 36% Confidence: low
emp-013 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 62-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 860 pg/mL."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 860 pg/mL."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 102."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 62-year-old man with chronic HFrEF."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 102."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 29."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 860 pg/mL."
Similarity: 34% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 29."
Similarity: 40% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 38% Confidence: low
emp-014 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 68-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 63% Confidence: high
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 61% Confidence: high
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 101."
Similarity: 62% Confidence: low
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: low
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 68-year-old woman with chronic HFrEF."
Similarity: 46% Confidence: low
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"Type 1 diabetes on insulin."
Similarity: 45% Confidence: low
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 101."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: low
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"Type 1 diabetes on insulin."
Similarity: 41% Confidence: low
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: low
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: low
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 810 pg/mL."
Similarity: 36% Confidence: low
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 32% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 23."
Similarity: 41% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 36% Confidence: low
emp-015 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.55)
  • No exclusion criteria met
Inclusion met: 9 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 74-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 31%."
Similarity: 66% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 31%."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,000 pg/mL."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP 2,000 pg/mL."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 31%."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,000 pg/mL."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium
inclusion MET
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 20 exactly on repeat labs."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 110."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 74-year-old man with chronic HFrEF."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 110."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 20 exactly on repeat labs."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 2,000 pg/mL."
Similarity: 36% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 36% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 35% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 31%."
Similarity: 42% Confidence: low
emp-016 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 59-year-old man with nonischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 770 pg/mL."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 770 pg/mL."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 49% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 59-year-old man with nonischemic HFrEF."
Similarity: 47% Confidence: medium
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100."
Similarity: 66% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 59-year-old man with nonischemic HFrEF."
Similarity: 58% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 59-year-old man with nonischemic HFrEF."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No diabetes."
Similarity: 36% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 34% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 61."
Similarity: 39% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 36% Confidence: low
emp-017 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 60% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 48% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 47% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 101."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 101."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 790 pg/mL."
Similarity: 33% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 32% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 41."
Similarity: 42% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 41% Confidence: low
emp-019 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 63-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 117."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 117."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 63-year-old woman with chronic HFrEF."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 810 pg/mL."
Similarity: 36% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 52."
Similarity: 38% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 37% Confidence: low
emp-021 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.52)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 60% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,200 pg/mL."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP 2,200 pg/mL."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,200 pg/mL."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 105."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 105."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 2,200 pg/mL."
Similarity: 36% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 36% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 35% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 26."
Similarity: 42% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 42% Confidence: low
emp-022 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 61-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 48% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100."
Similarity: 66% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 61-year-old man with chronic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 790 pg/mL."
Similarity: 33% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 44."
Similarity: 40% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 38% Confidence: low
emp-023 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 70-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 102."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 70-year-old man with chronic HFrEF."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 102."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 32% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 32% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 21."
Similarity: 39% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 37% Confidence: low
emp-024 GT: not enough information
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.55)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 65-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 60% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP was measured 14 months ago; no recent value available."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP was measured 14 months ago; no recent value available."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP was measured 14 months ago; no recent value available."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 65-year-old woman with chronic HFrEF."
Similarity: 49% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100."
Similarity: 66% Confidence: low
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 65-year-old woman with chronic HFrEF."
Similarity: 49% Confidence: low
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: low
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP was measured 14 months ago; no recent value available."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: low
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: low
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: low
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"eGFR 58."
Similarity: 37% Confidence: low
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 34% Confidence: low
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 32% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 58."
Similarity: 42% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 41% Confidence: low
emp-025 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.48)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 63% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,600 pg/mL."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,600 pg/mL."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,600 pg/mL."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 48% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 101 without symptoms."
Similarity: 71% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 101 without symptoms."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 20."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,600 pg/mL."
Similarity: 36% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 43% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 20."
Similarity: 40% Confidence: low
emp-027 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.52)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 74-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,300 pg/mL."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,300 pg/mL."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,300 pg/mL."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 106."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 74-year-old woman with chronic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 106."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 25."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,300 pg/mL."
Similarity: 34% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 31% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 25."
Similarity: 45% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 43% Confidence: low
emp-028 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 63-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 63% Confidence: high
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 61% Confidence: high
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 66% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 64% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 101."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 63-year-old man with chronic HFrEF."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 101."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 820 pg/mL."
Similarity: 34% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 23."
Similarity: 41% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 36% Confidence: low
emp-029 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 69-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 800 pg/mL."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 800 pg/mL."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 109."
Similarity: 58% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 69-year-old woman with chronic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 109."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 800 pg/mL."
Similarity: 34% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 32% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 19."
Similarity: 40% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 38% Confidence: low
emp-030 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 62-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100 without symptoms."
Similarity: 75% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 62-year-old man with chronic HFrEF."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100 without symptoms."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 27."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 37% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 27."
Similarity: 41% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 37% Confidence: low
emp-031 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.52)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 63% Confidence: high
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 61% Confidence: high
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"Hospitalized for worsening HF 6 months ago."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 104 without hypotensive symptoms."
Similarity: 75% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 104 without hypotensive symptoms."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
Similarity: 36% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 38% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 36% Confidence: low
emp-032 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.55)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 63% Confidence: high
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 61% Confidence: high
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,400 pg/mL."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 6 months ago."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP 2,400 pg/mL."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 106."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 106."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 6 months ago."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 41% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 34."
Similarity: 43% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 36% Confidence: low
emp-033 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.59)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 10 months ago."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,050 pg/mL."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,050 pg/mL."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,050 pg/mL."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 60% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 112."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 112."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 10 months ago."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,050 pg/mL."
Similarity: 36% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 43% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 41% Confidence: low
emp-034 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.59)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 10 months ago."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 49% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 60% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 111."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 111."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 10 months ago."
Similarity: 41% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 43% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 42% Confidence: low
emp-035 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.50)
  • No exclusion criteria met
Inclusion met: 9 Inclusion not met: 0 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 60% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 610 pg/mL."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 610 pg/mL."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"On full GDMT."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 109."
Similarity: 58% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On full GDMT."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On full GDMT."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 109."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 8 months ago."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 39% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 42% Confidence: low
emp-036 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.50)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 60% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"HF hospitalization 8 months ago."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 110."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 110."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 8 months ago."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 28."
Similarity: 41% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 42% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 42% Confidence: low
emp-037 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.52)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 7 months ago."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 52% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 118."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 118."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 7 months ago."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
Similarity: 35% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 43% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 40."
Similarity: 42% Confidence: low
emp-038 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.52)
  • No exclusion criteria met
Inclusion met: 10 Inclusion not met: 0 Unknown: 0 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,050 pg/mL."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 7 months ago."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"Atrial fibrillation documented."
Similarity: 48% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 47% Confidence: medium
inclusion MET
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"Atrial fibrillation documented."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 116."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 116."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 7 months ago."
Similarity: 40% Confidence: medium NEGATION DETECTED
emp-039 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 70-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 65% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 5 months ago."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,200 pg/mL."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 49% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 114."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"eGFR 19 mL/min/1.73 m² on repeat labs."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 114."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 5 months ago."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,200 pg/mL."
Similarity: 37% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 32%."
Similarity: 38% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 38% Confidence: low
emp-040 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 63-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 63% Confidence: high
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 61% Confidence: high
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 9 months ago."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100 mmHg at screening without clear symptoms."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100 mmHg at screening without clear symptoms."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 63-year-old man with chronic HFrEF."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 9 months ago."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"SBP 100 mmHg at screening without clear symptoms."
Similarity: 39% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 42% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 36% Confidence: low
emp-041 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 58-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 30%."
Similarity: 64% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 30%."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 11 months ago."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 30%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 30%."
Similarity: 49% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 700 pg/mL."
Similarity: 49% Confidence: medium
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 122."
Similarity: 52% Confidence: low
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: low
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 58-year-old woman with chronic HFrEF."
Similarity: 47% Confidence: low
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 122."
Similarity: 45% Confidence: low
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 11 months ago."
Similarity: 42% Confidence: low
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: low
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"Type 1 diabetes mellitus on insulin."
Similarity: 41% Confidence: low
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 39% Confidence: low
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"Type 1 diabetes mellitus on insulin."
Similarity: 38% Confidence: low
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: low
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 700 pg/mL."
Similarity: 31% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 30%."
Similarity: 40% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 30%."
Similarity: 39% Confidence: low
emp-042 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.52)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 63% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 6 months ago."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,150 pg/mL."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"Type 2 diabetes; he has been taking dapagliflozin for the last 3 months."
Similarity: 68% Confidence: low
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 108."
Similarity: 56% Confidence: low
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"Type 2 diabetes; he has been taking dapagliflozin for the last 3 months."
Similarity: 52% Confidence: low
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
Similarity: 51% Confidence: low
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 108."
Similarity: 49% Confidence: low
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: low
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 6 months ago."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 41% Confidence: low
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 39% Confidence: low
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 39% Confidence: low
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,150 pg/mL."
Similarity: 32% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 33%."
Similarity: 43% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 38."
Similarity: 42% Confidence: low
emp-043 GT: not enough information
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 60% Confidence: high
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 4 months ago."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP value is not available in current records."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP value is not available in current records."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF."
Similarity: 47% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"HF hospitalization 4 months ago."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 115."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 115."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP value is not available in current records."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 4 months ago."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 39% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 42% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 36% Confidence: low
emp-044 GT: excluded
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 65-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 60% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"His last HF hospitalization was 14 months ago with no admissions since."
Similarity: 49% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 119."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"His last HF hospitalization was 14 months ago with no admissions since."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"His last HF hospitalization was 14 months ago with no admissions since."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 119."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 39% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
Similarity: 35% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 42% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 41."
Similarity: 42% Confidence: low
emp-045 GT: included
Included

Обоснование:

  • + Male or female patient age >= 18 years at screenin... (score: 1.00)
  • + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
  • No exclusion criteria met
Inclusion met: 10 Inclusion not met: 0 Unknown: 0 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"Will provide informed consent."
Similarity: 67% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 31%."
Similarity: 66% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 31%."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,020 pg/mL."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 31%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 9 months ago."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 31%."
Similarity: 51% Confidence: medium
inclusion MET
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"Will provide informed consent."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 107 without hypotensive symptoms."
Similarity: 72% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 107 without hypotensive symptoms."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Will provide informed consent."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"Will provide informed consent."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 9 months ago."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 41% Confidence: medium NEGATION DETECTED

Excluded (Не подходят) 30

+
dapa-hf-001 GT: included
Excluded

Обоснование:

  • - EXCLUSION: Coronary revascularization (percutaneous coronary ... (score: 0.73)
  • - EXCLUSION: Previous cardiac transplantation or implantation o... (score: 0.75)
Inclusion met: 7 Inclusion not met: 0 Unknown: 0 Exclusion met: 2

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 67-year-old White man with a 3-year history of symptomatic chronic heart failure due to ischemic cardiomyopathy presents for routine follow-up."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"His estimated glomerular filtration rate (eGFR) is 45 mL/min/1.73 m² (CKD-EPI), and serum potassium is 4.5 mmol/L."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"There has been no hospitalization for acute decompensated heart failure in the last 6 months and no myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary revascularization, or cardiac device implantation within the last 12 months."
Similarity: 75% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"The patient is able to provide informed consent and is willing to comply with all study visits and procedures."
Similarity: 74% Confidence: high
exclusion MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"There has been no hospitalization for acute decompensated heart failure in the last 6 months and no myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary revascularization, or cardiac device implantation within the last 12 months."
Similarity: 73% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP measured last week was 2,100 pg/mL, clearly elevated."
Similarity: 72% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"Current medications include an ACE inhibitor, a beta-blocker, a mineralocorticoid receptor antagonist, and a loop diuretic, in doses consistent with guideline-directed medical therapy for HFrEF."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"Current medications include an ACE inhibitor, a beta-blocker, a mineralocorticoid receptor antagonist, and a loop diuretic, in doses consistent with guideline-directed medical therapy for HFrEF."
Similarity: 60% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"Echocardiography one month ago showed a left ventricular ejection fraction (LVEF) of 30% with global hypokinesis."
Similarity: 54% Confidence: medium
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"There has been no hospitalization for acute decompensated heart failure in the last 6 months and no myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary revascularization, or cardiac device implantation within the last 12 months."
Similarity: 76% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"There is no evidence of restrictive, hypertrophic, or constrictive cardiomyopathy, active myocarditis, or significant uncorrected valvular disease, and he has no symptomatic bradycardia or high-grade AV block."
Similarity: 72% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"He has no history of type 1 diabetes mellitus and has never received an SGLT2 inhibitor."
Similarity: 72% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"Current medications include an ACE inhibitor, a beta-blocker, a mineralocorticoid receptor antagonist, and a loop diuretic, in doses consistent with guideline-directed medical therapy for HFrEF."
Similarity: 64% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"There is no evidence of restrictive, hypertrophic, or constrictive cardiomyopathy, active myocarditis, or significant uncorrected valvular disease, and he has no symptomatic bradycardia or high-grade AV block."
Similarity: 58% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"There has been no hospitalization for acute decompensated heart failure in the last 6 months and no myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary revascularization, or cardiac device implantation within the last 12 months."
Similarity: 54% Confidence: low
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"He has no history of type 1 diabetes mellitus and has never received an SGLT2 inhibitor."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"Blood pressure at today’s visit is 118/72 mmHg without symptoms of hypotension."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"His estimated glomerular filtration rate (eGFR) is 45 mL/min/1.73 m² (CKD-EPI), and serum potassium is 4.5 mmol/L."
Similarity: 0% Confidence: high
dapa-hf-002 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Coronary revascularization (percutaneous coronary ... (score: 0.66)
  • - EXCLUSION: Previous cardiac transplantation or implantation o... (score: 0.72)
Inclusion met: 7 Inclusion not met: 0 Unknown: 0 Exclusion met: 2

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 59-year-old Asian woman with a 2-year history of chronic systolic heart failure of nonischemic etiology presents to the heart failure clinic."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"A transthoracic echocardiogram performed 3 weeks ago demonstrated an LVEF of 35% with mild left ventricular dilation."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"Her eGFR is 62 mL/min/1.73 m², with stable renal function over the last year."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"The patient understands the protocol and is willing to provide informed consent and attend all visits."
Similarity: 72% Confidence: high
exclusion MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"There has been no recent myocardial infarction, unstable angina, stroke, TIA, coronary revascularization, or cardiac resynchronization therapy within the past year."
Similarity: 72% Confidence: high
exclusion MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"There has been no recent myocardial infarction, unstable angina, stroke, TIA, coronary revascularization, or cardiac resynchronization therapy within the past year."
Similarity: 66% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"She reports NYHA class II exertional dyspnea without recent hospitalizations for heart failure."
Similarity: 61% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP is 1,450 pg/mL, consistent with symptomatic HFrEF."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"She is receiving guideline-directed standard of care, including an ARNI, a beta-blocker, an MRA, and a loop diuretic."
Similarity: 51% Confidence: medium
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"There has been no recent myocardial infarction, unstable angina, stroke, TIA, coronary revascularization, or cardiac resynchronization therapy within the past year."
Similarity: 81% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"She has no history of type 1 diabetes, significant valvular disease, restrictive or hypertrophic cardiomyopathy, or high-grade AV block."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"She has no history of type 1 diabetes, significant valvular disease, restrictive or hypertrophic cardiomyopathy, or high-grade AV block."
Similarity: 59% Confidence: low
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"Three weeks ago, her diabetologist initiated empagliflozin 10 mg once daily for type 2 diabetes mellitus, and she has tolerated it well."
Similarity: 57% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"She is receiving guideline-directed standard of care, including an ARNI, a beta-blocker, an MRA, and a loop diuretic."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"There has been no recent myocardial infarction, unstable angina, stroke, TIA, coronary revascularization, or cardiac resynchronization therapy within the past year."
Similarity: 51% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"She has not experienced symptomatic hypotension; current blood pressure is 110/68 mmHg."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"She has no history of type 1 diabetes, significant valvular disease, restrictive or hypertrophic cardiomyopathy, or high-grade AV block."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"Her eGFR is 62 mL/min/1.73 m², with stable renal function over the last year."
Similarity: 0% Confidence: high
dapa-hf-003 GT: included
Excluded

Обоснование:

  • - EXCLUSION: Implantation of a CRT within 12 weeks prior to enr... (score: 0.63)
Inclusion met: 7 Inclusion not met: 0 Unknown: 0 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"An 82-year-old Hispanic man with ischemic cardiomyopathy and chronic heart failure presents for evaluation."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"Echocardiography 2 months ago showed an LVEF of 32% and moderate left ventricular enlargement."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"Renal function is stable with an eGFR of 38 mL/min/1.73 m² and no evidence of rapidly progressive kidney disease."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP is 1,900 pg/mL."
Similarity: 69% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"He has had symptomatic HFrEF for 4 years, currently NYHA class II–III with fatigue and exertional dyspnea but no resting symptoms."
Similarity: 67% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Cognitively intact, he is able to sign informed consent and adhere to protocol requirements."
Similarity: 67% Confidence: high
exclusion MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"He has not been hospitalized for acute decompensated heart failure in the last 5 months and has not had MI, unstable angina, stroke, TIA, coronary revascularization, valve surgery, or implantation of CRT or ventricular assist devices within the last year."
Similarity: 63% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"He has had symptomatic HFrEF for 4 years, currently NYHA class II–III with fatigue and exertional dyspnea but no resting symptoms."
Similarity: 57% Confidence: medium
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"There is no clinical or imaging evidence of restrictive cardiomyopathy, hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, or uncorrected primary valvular disease."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"He has not been hospitalized for acute decompensated heart failure in the last 5 months and has not had MI, unstable angina, stroke, TIA, coronary revascularization, valve surgery, or implantation of CRT or ventricular assist devices within the last year."
Similarity: 79% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"He has never been exposed to an SGLT2 inhibitor and has no history of type 1 diabetes mellitus."
Similarity: 74% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"He has not been hospitalized for acute decompensated heart failure in the last 5 months and has not had MI, unstable angina, stroke, TIA, coronary revascularization, valve surgery, or implantation of CRT or ventricular assist devices within the last year."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"He has not been hospitalized for acute decompensated heart failure in the last 5 months and has not had MI, unstable angina, stroke, TIA, coronary revascularization, valve surgery, or implantation of CRT or ventricular assist devices within the last year."
Similarity: 68% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"He has not been hospitalized for acute decompensated heart failure in the last 5 months and has not had MI, unstable angina, stroke, TIA, coronary revascularization, valve surgery, or implantation of CRT or ventricular assist devices within the last year."
Similarity: 64% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"Blood pressure today is 122/70 mmHg; he denies dizziness or other symptoms of hypotension."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"Blood pressure today is 122/70 mmHg; he denies dizziness or other symptoms of hypotension."
Similarity: 50% Confidence: low
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"He has never been exposed to an SGLT2 inhibitor and has no history of type 1 diabetes mellitus."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"Renal function is stable with an eGFR of 38 mL/min/1.73 m² and no evidence of rapidly progressive kidney disease."
Similarity: 0% Confidence: high
dapa-hf-004 GT: excluded
Excluded

Обоснование:

  • - NOT MET: LVEF≤40% (score: 0.00)
Inclusion met: 6 Inclusion not met: 1 Unknown: 0 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 70-year-old Black woman with a history of hypertension and chronic heart failure presents with exertional dyspnea and mild ankle edema."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"Renal function is preserved with an eGFR of 72 mL/min/1.73 m²."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"The patient is able and willing to provide informed consent and comply with all trial procedures."
Similarity: 73% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"There is no evidence of restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or significant valvular disease."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP is 900 pg/mL, mildly elevated."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"There is no evidence of restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or significant valvular disease."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"There is no evidence of restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or significant valvular disease."
Similarity: 81% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"She has not had recent MI, unstable angina, stroke, TIA, coronary revascularization, acute decompensated HF hospitalizations, or device implantations within the last 6 months."
Similarity: 79% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"She has not had recent MI, unstable angina, stroke, TIA, coronary revascularization, acute decompensated HF hospitalizations, or device implantations within the last 6 months."
Similarity: 75% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"She has never received an SGLT2 inhibitor and has no history of type 1 diabetes mellitus."
Similarity: 71% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"She has not had recent MI, unstable angina, stroke, TIA, coronary revascularization, acute decompensated HF hospitalizations, or device implantations within the last 6 months."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"There is no evidence of restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or significant valvular disease."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"She has not had recent MI, unstable angina, stroke, TIA, coronary revascularization, acute decompensated HF hospitalizations, or device implantations within the last 6 months."
Similarity: 51% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"Blood pressure today is 130/76 mmHg without symptoms of hypotension."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"She has never received an SGLT2 inhibitor and has no history of type 1 diabetes mellitus."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"There is no evidence of restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or significant valvular disease."
Similarity: 46% Confidence: low
inclusion NOT MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"Echocardiography 6 weeks ago demonstrated a left ventricular ejection fraction of 45% with concentric hypertrophy and normal cavity size."
Similarity: 0% Confidence: high
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"Renal function is preserved with an eGFR of 72 mL/min/1.73 m²."
Similarity: 0% Confidence: high
dapa-hf-005 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unst... (score: 1.00)
  • - NOT MET: eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enro... (score: 0.00)
Inclusion met: 6 Inclusion not met: 1 Unknown: 0 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 64-year-old White man with long-standing ischemic heart disease and chronic systolic heart failure presents for routine review."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"Echocardiography performed 1 month ago showed an LVEF of 28% with akinetic segments in the anterior wall and apex."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"Laboratory tests show an eGFR of 25 mL/min/1.73 m² (CKD-EPI) on repeated measurements, indicating severe chronic kidney disease."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP is 2,300 pg/mL, markedly elevated."
Similarity: 79% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"The patient understands the study requirements and is willing to sign informed consent."
Similarity: 75% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"There is no evidence of restrictive or hypertrophic cardiomyopathy, active myocarditis, or severe uncorrected valvular disease."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 64-year-old White man with long-standing ischemic heart disease and chronic systolic heart failure presents for routine review."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"There has been no recent MI, unstable angina, stroke, TIA, revascularization, or device implantation within the previous year."
Similarity: 81% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"There has been no recent MI, unstable angina, stroke, TIA, revascularization, or device implantation within the previous year."
Similarity: 76% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"There is no evidence of restrictive or hypertrophic cardiomyopathy, active myocarditis, or severe uncorrected valvular disease."
Similarity: 75% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"He has no history of type 1 diabetes and has not used SGLT2 inhibitors."
Similarity: 72% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"There has been no recent MI, unstable angina, stroke, TIA, revascularization, or device implantation within the previous year."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"A 64-year-old White man with long-standing ischemic heart disease and chronic systolic heart failure presents for routine review."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"He has no history of type 1 diabetes and has not used SGLT2 inhibitors."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"There has been no recent MI, unstable angina, stroke, TIA, revascularization, or device implantation within the previous year."
Similarity: 50% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"There is no evidence of restrictive or hypertrophic cardiomyopathy, active myocarditis, or severe uncorrected valvular disease."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"There has been no recent MI, unstable angina, stroke, TIA, revascularization, or device implantation within the previous year."
Similarity: 43% Confidence: medium NEGATION DETECTED
inclusion NOT MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"Laboratory tests show an eGFR of 25 mL/min/1.73 m² (CKD-EPI) on repeated measurements, indicating severe chronic kidney disease."
Similarity: 0% Confidence: high
dapa-hf-006 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Coronary revascularization (percutaneous coronary ... (score: 0.63)
Inclusion met: 7 Inclusion not met: 0 Unknown: 0 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 72-year-old Caucasian woman with known ischemic cardiomyopathy and chronic heart failure presents after a recent coronary event."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"Echocardiography 2 months ago showed an LVEF of 33% with dilated LV."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"Her eGFR is 52 mL/min/1.73 m² with stable renal function."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"She has had symptomatic HFrEF for 5 years and is currently NYHA class II–III."
Similarity: 72% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP is 1,750 pg/mL."
Similarity: 72% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"She is willing and able to give informed consent and comply with study follow-up."
Similarity: 65% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"She has had symptomatic HFrEF for 5 years and is currently NYHA class II–III."
Similarity: 64% Confidence: high
exclusion MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"A 72-year-old Caucasian woman with known ischemic cardiomyopathy and chronic heart failure presents after a recent coronary event."
Similarity: 63% Confidence: medium
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"She has no history of type 1 diabetes, restrictive or hypertrophic cardiomyopathy, active myocarditis, or significant uncorrected valvular disease."
Similarity: 68% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"She takes a beta-blocker, ACE inhibitor, MRA, and loop diuretic in guideline-directed doses and has never used an SGLT2 inhibitor."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"Since discharge, she has been clinically stable without recurrent chest pain or decompensated HF."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"A 72-year-old Caucasian woman with known ischemic cardiomyopathy and chronic heart failure presents after a recent coronary event."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"She has no history of type 1 diabetes, restrictive or hypertrophic cardiomyopathy, active myocarditis, or significant uncorrected valvular disease."
Similarity: 56% Confidence: low
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"A 72-year-old Caucasian woman with known ischemic cardiomyopathy and chronic heart failure presents after a recent coronary event."
Similarity: 54% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"Blood pressure is 116/70 mmHg without symptoms of hypotension."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"Since discharge, she has been clinically stable without recurrent chest pain or decompensated HF."
Similarity: 50% Confidence: low
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"She has no history of type 1 diabetes, restrictive or hypertrophic cardiomyopathy, active myocarditis, or significant uncorrected valvular disease."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"Her eGFR is 52 mL/min/1.73 m² with stable renal function."
Similarity: 0% Confidence: high
dapa-hf-007 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Type 1 diabetes mellitus (score: 0.48)
  • - EXCLUSION: Coronary revascularization (percutaneous coronary ... (score: 0.64)
Inclusion met: 7 Inclusion not met: 0 Unknown: 0 Exclusion met: 3

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 61-year-old White man with a 3-year history of chronic heart failure secondary to dilated cardiomyopathy presents for optimization of therapy."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"Echocardiography 1 month ago demonstrated an LVEF of 35% with diffuse hypokinesis."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"His eGFR is 58 mL/min/1.73 m², with stable renal function on serial measurements."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"Over the past year, he has not experienced acute decompensated HF hospitalization, MI, unstable angina, stroke, TIA, revascularization procedures, or cardiac device implantation."
Similarity: 74% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP is 1,300 pg/mL."
Similarity: 71% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"The patient is cognitively intact, able to provide informed consent, and willing to comply with protocol requirements."
Similarity: 67% Confidence: high
exclusion MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"Over the past year, he has not experienced acute decompensated HF hospitalization, MI, unstable angina, stroke, TIA, revascularization procedures, or cardiac device implantation."
Similarity: 64% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"There is no evidence of restrictive or hypertrophic cardiomyopathy, myocarditis, constrictive pericarditis, or significant uncorrected valvular disease."
Similarity: 57% Confidence: medium
exclusion MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"Since childhood he has had type 1 diabetes mellitus managed with a basal-bolus insulin regimen; there is no history of SGLT2 inhibitor use."
Similarity: 48% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"There is no evidence of restrictive or hypertrophic cardiomyopathy, myocarditis, constrictive pericarditis, or significant uncorrected valvular disease."
Similarity: 48% Confidence: medium
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"There is no evidence of restrictive or hypertrophic cardiomyopathy, myocarditis, constrictive pericarditis, or significant uncorrected valvular disease."
Similarity: 80% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"Over the past year, he has not experienced acute decompensated HF hospitalization, MI, unstable angina, stroke, TIA, revascularization procedures, or cardiac device implantation."
Similarity: 74% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"Since childhood he has had type 1 diabetes mellitus managed with a basal-bolus insulin regimen; there is no history of SGLT2 inhibitor use."
Similarity: 64% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"Over the past year, he has not experienced acute decompensated HF hospitalization, MI, unstable angina, stroke, TIA, revascularization procedures, or cardiac device implantation."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"Current blood pressure is 122/74 mmHg without symptomatic hypotension."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"Current blood pressure is 122/74 mmHg without symptomatic hypotension."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"Over the past year, he has not experienced acute decompensated HF hospitalization, MI, unstable angina, stroke, TIA, revascularization procedures, or cardiac device implantation."
Similarity: 46% Confidence: low
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"His eGFR is 58 mL/min/1.73 m², with stable renal function on serial measurements."
Similarity: 0% Confidence: high
dapa-hf-008 GT: excluded
Excluded

Обоснование:

  • - NOT MET: LVEF≤40% (score: 0.00)
Inclusion met: 6 Inclusion not met: 1 Unknown: 0 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 54-year-old Asian woman with long-standing hypertrophic obstructive cardiomyopathy presents with progressive exertional dyspnea and chest discomfort."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR is 68 mL/min/1.73 m² with normal renal function."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP is 1,200 pg/mL."
Similarity: 74% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"Echocardiography 2 weeks ago showed asymmetric septal hypertrophy with dynamic LV outflow tract obstruction and a preserved LVEF of 60%; there is no dilated, systolic-type cardiomyopathy."
Similarity: 71% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"She is able to give informed consent and is interested in participating in research."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"Her medications include a beta-blocker and calcium channel blocker; she has never received an SGLT2 inhibitor and has no diabetes."
Similarity: 49% Confidence: medium
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"There is no evidence of restrictive cardiomyopathy or active myocarditis, but the hypertrophic obstructive cardiomyopathy is considered the primary cause of her heart failure."
Similarity: 79% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"She has not had MI, stroke, TIA, or recent revascularization, and there have been no hospitalizations for acute decompensated heart failure in the last 3 months."
Similarity: 72% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"She has not had MI, stroke, TIA, or recent revascularization, and there have been no hospitalizations for acute decompensated heart failure in the last 3 months."
Similarity: 71% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"Her medications include a beta-blocker and calcium channel blocker; she has never received an SGLT2 inhibitor and has no diabetes."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"She has not had MI, stroke, TIA, or recent revascularization, and there have been no hospitalizations for acute decompensated heart failure in the last 3 months."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"She has not had MI, stroke, TIA, or recent revascularization, and there have been no hospitalizations for acute decompensated heart failure in the last 3 months."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"Blood pressure today is 118/72 mmHg without symptoms of hypotension."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"Her medications include a beta-blocker and calcium channel blocker; she has never received an SGLT2 inhibitor and has no diabetes."
Similarity: 47% Confidence: low
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"She has not had MI, stroke, TIA, or recent revascularization, and there have been no hospitalizations for acute decompensated heart failure in the last 3 months."
Similarity: 47% Confidence: low
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"Her medications include a beta-blocker and calcium channel blocker; she has never received an SGLT2 inhibitor and has no diabetes."
Similarity: 39% Confidence: medium NEGATION DETECTED
inclusion NOT MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"Echocardiography 2 weeks ago showed asymmetric septal hypertrophy with dynamic LV outflow tract obstruction and a preserved LVEF of 60%; there is no dilated, systolic-type cardiomyopathy."
Similarity: 0% Confidence: high
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR is 68 mL/min/1.73 m² with normal renal function."
Similarity: 0% Confidence: high
dapa-hf-009 GT: not enough information
Excluded

Обоснование:

  • - NOT MET: Established documented diagnosis of symptomatic HF... (score: 0.84)
  • - NOT MET: Patients should receive background standard of car... (score: 0.69)
Inclusion met: 4 Inclusion not met: 2 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 48-year-old Hispanic man presents with a 3-week history of exertional shortness of breath and fatigue following a viral respiratory illness."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"The patient is willing to provide informed consent and comply with a clinical trial, but additional diagnostic workup is still in progress."
Similarity: 72% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP has not yet been measured, and renal function tests are pending; there is no known history of chronic kidney disease."
Similarity: 67% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"It is not yet known whether he will require hospitalization for acute decompensated heart failure or whether symptoms will persist beyond 2 months to meet criteria for chronic HFrEF."
Similarity: 58% Confidence: medium
inclusion NOT MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"It is not yet known whether he will require hospitalization for acute decompensated heart failure or whether symptoms will persist beyond 2 months to meet criteria for chronic HFrEF."
Similarity: 84% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"There is no history of prior myocardial infarction, coronary revascularization, stroke, TIA, or device implantation."
Similarity: 77% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"There is no history of prior myocardial infarction, coronary revascularization, stroke, TIA, or device implantation."
Similarity: 71% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"He has no history of type 1 diabetes and is not taking any SGLT2 inhibitors."
Similarity: 70% Confidence: high NEGATION DETECTED
inclusion NOT MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"It is not yet known whether he will require hospitalization for acute decompensated heart failure or whether symptoms will persist beyond 2 months to meet criteria for chronic HFrEF."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"He has no prior diagnosis of chronic heart failure."
Similarity: 69% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"There is no history of prior myocardial infarction, coronary revascularization, stroke, TIA, or device implantation."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"It is not yet known whether he will require hospitalization for acute decompensated heart failure or whether symptoms will persist beyond 2 months to meet criteria for chronic HFrEF."
Similarity: 63% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"The patient is willing to provide informed consent and comply with a clinical trial, but additional diagnostic workup is still in progress."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"He has no history of type 1 diabetes and is not taking any SGLT2 inhibitors."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"There is no history of prior myocardial infarction, coronary revascularization, stroke, TIA, or device implantation."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"There is no history of prior myocardial infarction, coronary revascularization, stroke, TIA, or device implantation."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"There is no history of prior myocardial infarction, coronary revascularization, stroke, TIA, or device implantation."
Similarity: 45% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"Physical examination reveals mild bilateral basal crackles and trace ankle edema, with otherwise stable vital signs and blood pressure 120/78 mmHg."
Similarity: 42% Confidence: low
dapa-hf-010 GT: not enough information
Excluded

Обоснование:

  • - NOT MET: Elevated NT-proBNP levels (score: 0.61)
  • - NOT MET: eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enro... (score: 0.61)
Inclusion met: 5 Inclusion not met: 2 Unknown: 0 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 63-year-old Black woman with a known diagnosis of chronic heart failure of unclear etiology presents for follow-up."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"She states that she would be willing to provide informed consent and attend trial visits, but further diagnostic clarification (including updated echocardiography, NT-proBNP, and renal function) has been recommended."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"She states that she would be willing to provide informed consent and attend trial visits, but further diagnostic clarification (including updated echocardiography, NT-proBNP, and renal function) has been recommended."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"She recalls having an echocardiogram about 9 months ago, but the exact left ventricular ejection fraction is not documented in the available records, and the report is not accessible at today’s visit."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"She recalls having an echocardiogram about 9 months ago, but the exact left ventricular ejection fraction is not documented in the available records, and the report is not accessible at today’s visit."
Similarity: 53% Confidence: medium
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"There is no documentation of recent MI, unstable angina, stroke, TIA, coronary revascularization, or device implantation in the last year, but this has not been systematically confirmed."
Similarity: 77% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"There is no documentation of recent MI, unstable angina, stroke, TIA, coronary revascularization, or device implantation in the last year, but this has not been systematically confirmed."
Similarity: 75% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"Her primary care notes mention “mild chronic kidney disease,” but there are no recent laboratory values from which to calculate eGFR; the most recent serum creatinine is from more than a year ago."
Similarity: 72% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"She does not have a history of type 1 diabetes and has never taken any SGLT2 inhibitor."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"There is no documentation of recent MI, unstable angina, stroke, TIA, coronary revascularization, or device implantation in the last year, but this has not been systematically confirmed."
Similarity: 67% Confidence: high NEGATION DETECTED
inclusion NOT MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"No recent NT-proBNP or BNP measurements are available in the electronic medical record."
Similarity: 61% Confidence: high NEGATION DETECTED
inclusion NOT MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"Her primary care notes mention “mild chronic kidney disease,” but there are no recent laboratory values from which to calculate eGFR; the most recent serum creatinine is from more than a year ago."
Similarity: 61% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"Based on currently available data, it is not possible to determine whether she fulfills all key inclusion and exclusion criteria for the dapagliflozin heart failure trial."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"She states that she would be willing to provide informed consent and attend trial visits, but further diagnostic clarification (including updated echocardiography, NT-proBNP, and renal function) has been recommended."
Similarity: 53% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"She is taking a beta-blocker and an ACE inhibitor at moderate doses, but no MRA or loop diuretic has been prescribed, and it is unclear whether she is on fully optimized guideline-directed therapy."
Similarity: 50% Confidence: low
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"She is taking a beta-blocker and an ACE inhibitor at moderate doses, but no MRA or loop diuretic has been prescribed, and it is unclear whether she is on fully optimized guideline-directed therapy."
Similarity: 50% Confidence: low
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"She does not have a history of type 1 diabetes and has never taken any SGLT2 inhibitor."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"Current blood pressure is 124/80 mmHg without symptoms of hypotension."
Similarity: 47% Confidence: medium NEGATION DETECTED
dapa-005 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unst... (score: 1.00)
  • - NOT MET: eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enro... (score: 0.00)
Inclusion met: 6 Inclusion not met: 1 Unknown: 0 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 65-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 29."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Will consent."
Similarity: 68% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 720 pg/mL."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"On standard HF therapy."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
Similarity: 71% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"On standard HF therapy."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"Will consent."
Similarity: 40% Confidence: medium NEGATION DETECTED
inclusion NOT MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 29."
Similarity: 0% Confidence: high
dapa-006 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Symptomatic hypotension or systolic BP <95 mmHg at... (score: 1.00)
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 60-year-old man with HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 55."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 94 mmHg with occasional lightheadedness on standing."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 670 pg/mL."
Similarity: 64% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 60-year-old man with HFrEF."
Similarity: 54% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 55."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 31% Confidence: low
dapa-008 GT: excluded
Excluded

Обоснование:

  • - NOT MET: LVEF≤40% (score: 0.00)
Inclusion met: 5 Inclusion not met: 1 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 62-year-old woman with dilated cardiomyopathy."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 60."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 680 pg/mL."
Similarity: 64% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
Similarity: 65% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
inclusion NOT MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 41% on recent echo."
Similarity: 0% Confidence: high
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 60."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 120."
Similarity: 33% Confidence: low
dapa-010 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Type 1 diabetes mellitus (score: 0.74)
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 59-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 50."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"Type 1 diabetes since adolescence on insulin."
Similarity: 74% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 640 pg/mL."
Similarity: 64% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 59-year-old man with chronic HFrEF."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No prior SGLT2 inhibitor."
Similarity: 74% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 110."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 50."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 110."
Similarity: 34% Confidence: low
dapa-013 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Receiving therapy with an SGLT2 inhibitor within 8... (score: 0.82)
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 67-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 33."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"Started empagliflozin 8 weeks ago for T2DM."
Similarity: 82% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 610 pg/mL."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 67-year-old woman with chronic HFrEF."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent MI/stroke."
Similarity: 73% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent MI/stroke."
Similarity: 64% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent MI/stroke."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 97 without symptoms."
Similarity: 59% Confidence: low
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: low
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: low
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No recent MI/stroke."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"Started empagliflozin 8 weeks ago for T2DM."
Similarity: 38% Confidence: low
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 33."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 97 without symptoms."
Similarity: 33% Confidence: low
dapa-015 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unst... (score: 1.00)
  • - NOT MET: eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enro... (score: 0.00)
Inclusion met: 5 Inclusion not met: 1 Unknown: 1 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 73-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 28."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 2,400 pg/mL."
Similarity: 72% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 108."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 33% Confidence: medium NEGATION DETECTED
inclusion NOT MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 28."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 29%."
Similarity: 35% Confidence: low
dapa-020 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Symptomatic hypotension or systolic BP <95 mmHg at... (score: 1.00)
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 60-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 49."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 93."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 630 pg/mL."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 60-year-old man with chronic HFrEF."
Similarity: 53% Confidence: medium
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 82% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"On ACEi + beta-blocker."
Similarity: 34% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 49."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 33% Confidence: low
dapa-023 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Receiving therapy with an SGLT2 inhibitor within 8... (score: 0.72)
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 67-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 35."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"Started dapagliflozin 6 weeks ago outside trial."
Similarity: 72% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 620 pg/mL."
Similarity: 60% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 67-year-old man with chronic HFrEF."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 47% Confidence: medium
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 51% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 47% Confidence: low
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 45% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 115."
Similarity: 44% Confidence: low
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 44% Confidence: low
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA III."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"Started dapagliflozin 6 weeks ago outside trial."
Similarity: 38% Confidence: low
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 35."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 35% Confidence: low
dapa-025 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unst... (score: 1.00)
  • - NOT MET: eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enro... (score: 0.00)
Inclusion met: 5 Inclusion not met: 1 Unknown: 1 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 70-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 29."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 610 pg/mL."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 70-year-old man with chronic HFrEF."
Similarity: 52% Confidence: medium
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: low
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: low
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: low
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 32% Confidence: low
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"eGFR 29."
Similarity: 32% Confidence: low
inclusion NOT MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 29."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 33% Confidence: low
dapa-034 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unst... (score: 1.00)
  • - NOT MET: eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enro... (score: 0.00)
Inclusion met: 5 Inclusion not met: 1 Unknown: 1 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 66-year-old man with nonischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 29 on two recent measurements."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 720 pg/mL."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 66-year-old man with nonischemic HFrEF."
Similarity: 53% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 67% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
inclusion NOT MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 29 on two recent measurements."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"No recent CV events."
Similarity: 37% Confidence: low
dapa-035 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Symptomatic hypotension or systolic BP <95 mmHg at... (score: 1.00)
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 64-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 52."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 94 mmHg, even though she denies dizziness."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
Similarity: 64% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 64-year-old woman with chronic HFrEF."
Similarity: 55% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 52."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 34% Confidence: low
dapa-036 GT: excluded
Excluded

Обоснование:

  • - NOT MET: LVEF≤40% (score: 0.00)
Inclusion met: 5 Inclusion not met: 1 Unknown: 1 Exclusion met: 0

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HF symptoms."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 46."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 700 pg/mL."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 49% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 54% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
Similarity: 52% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 122."
Similarity: 40% Confidence: medium NEGATION DETECTED
inclusion NOT MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 41% on echo 3 weeks ago."
Similarity: 0% Confidence: high
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 46."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 34% Confidence: low
dapa-037 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Type 1 diabetes mellitus (score: 0.72)
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 58-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 60."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"Type 1 diabetes mellitus since adolescence on insulin."
Similarity: 72% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 680 pg/mL."
Similarity: 64% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 50% Confidence: medium
exclusion NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No prior SGLT2 inhibitor use."
Similarity: 70% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 115."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 60."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Sinus rhythm."
Similarity: 34% Confidence: low
dapa-038 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Receiving therapy with an SGLT2 inhibitor within 8... (score: 0.73)
Inclusion met: 6 Inclusion not met: 0 Unknown: 1 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 65-year-old woman with ischemic HFrEF."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 35%."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 48."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"Type 2 diabetes; empagliflozin was started 4 weeks ago."
Similarity: 73% Confidence: high
inclusion MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 740 pg/mL."
Similarity: 67% Confidence: high
inclusion MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 65-year-old woman with ischemic HFrEF."
Similarity: 52% Confidence: medium
exclusion NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent MI/stroke."
Similarity: 73% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent MI/stroke."
Similarity: 64% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent MI/stroke."
Similarity: 62% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 57% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 56% Confidence: low
exclusion NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: low
exclusion NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 109."
Similarity: 46% Confidence: low
exclusion NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"Type 2 diabetes; empagliflozin was started 4 weeks ago."
Similarity: 44% Confidence: low
exclusion NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No recent MI/stroke."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 48."
Similarity: 0% Confidence: high
inclusion UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 109."
Similarity: 36% Confidence: low
emp-003 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Symptomatic hypotension and/or a SBP < 100 mmHg (score: 1.00)
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 64-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 99 mmHg without clear hypotensive symptoms."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 58% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 64-year-old man with chronic HFrEF."
Similarity: 57% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 64-year-old man with chronic HFrEF."
Similarity: 47% Confidence: medium
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 64-year-old man with chronic HFrEF."
Similarity: 51% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 99 mmHg without clear hypotensive symptoms."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 45% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 44% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"eGFR 45."
Similarity: 34% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
Similarity: 42% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 38%."
Similarity: 37% Confidence: low
emp-010 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Symptomatic hypotension and/or a SBP < 100 mmHg (score: 1.00)
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 60-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 98 and reports mild presyncope in the last week."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 60% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 60-year-old woman with chronic HFrEF."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 820 pg/mL."
Similarity: 47% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 98 and reports mild presyncope in the last week."
Similarity: 57% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"SBP 98 and reports mild presyncope in the last week."
Similarity: 55% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 60-year-old woman with chronic HFrEF."
Similarity: 53% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 820 pg/mL."
Similarity: 34% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"eGFR 48."
Similarity: 32% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 41% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 37%."
Similarity: 38% Confidence: low
emp-012 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Symptomatic hypotension and/or a SBP < 100 mmHg (score: 0.75)
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 65-year-old woman with chronic HFrEF."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100 without symptoms."
Similarity: 75% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 47% Confidence: medium
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"Started dapagliflozin 2 months ago for diabetes."
Similarity: 65% Confidence: low
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"Started dapagliflozin 2 months ago for diabetes."
Similarity: 59% Confidence: low
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 65-year-old woman with chronic HFrEF."
Similarity: 49% Confidence: low
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100 without symptoms."
Similarity: 48% Confidence: low
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: low
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 43% Confidence: low
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 41% Confidence: low
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 39% Confidence: low
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 37% Confidence: low
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 780 pg/mL."
Similarity: 34% Confidence: low
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"Started dapagliflozin 2 months ago for diabetes."
Similarity: 33% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 43% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 50."
Similarity: 41% Confidence: low
emp-018 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Symptomatic hypotension and/or a SBP < 100 mmHg (score: 1.00)
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 71-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 99 without documented symptoms."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 59% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 56% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 54% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 52% Confidence: medium
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 840 pg/mL."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 60% Confidence: high NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 99 without documented symptoms."
Similarity: 49% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 48% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 71-year-old man with chronic HFrEF."
Similarity: 46% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 27."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II–III."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 840 pg/mL."
Similarity: 32% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 31% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 34%."
Similarity: 43% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 27."
Similarity: 41% Confidence: low
emp-020 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Symptomatic hypotension and/or a SBP < 100 mmHg (score: 1.00)
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 98 with occasional dizziness."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 63% Confidence: high
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 62% Confidence: high
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 61% Confidence: high
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 98 with occasional dizziness."
Similarity: 54% Confidence: low
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
Similarity: 51% Confidence: low
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: low
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: low
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 24."
Similarity: 40% Confidence: low
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: low
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: low
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 34% Confidence: low
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 830 pg/mL."
Similarity: 34% Confidence: low
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"eGFR 24."
Similarity: 33% Confidence: low
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 32% Confidence: low
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 24."
Similarity: 41% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
Similarity: 36% Confidence: low
emp-026 GT: excluded
Excluded

Обоснование:

  • - EXCLUSION: Symptomatic hypotension and/or a SBP < 100 mmHg (score: 1.00)
Inclusion met: 8 Inclusion not met: 0 Unknown: 2 Exclusion met: 1

Анализ критериев:

inclusion MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 57-year-old man with chronic HFrEF."
Similarity: 100% Confidence: high
exclusion MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 99."
Similarity: 100% Confidence: high
inclusion MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 55% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 53% Confidence: medium
inclusion MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 810 pg/mL."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 57-year-old man with chronic HFrEF."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 50% Confidence: medium
inclusion MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 46% Confidence: medium
exclusion NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 59% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 57-year-old man with chronic HFrEF."
Similarity: 50% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 47% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 99."
Similarity: 43% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 42% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 41% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 40% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 38% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
Similarity: 37% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 810 pg/mL."
Similarity: 36% Confidence: medium NEGATION DETECTED
exclusion NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"eGFR 49."
Similarity: 32% Confidence: medium NEGATION DETECTED
inclusion UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 49."
Similarity: 39% Confidence: low
inclusion UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 40%."
Similarity: 36% Confidence: low